The Italian Chamber of Deputies has submitted an opinion to the Council Presidency on the proposed European Biotech Act, assessing its compliance with the Principles of Subsidiarity and Proportionality. The opinion, sent on 23 June 2026, concerns the Commission's proposal for a regulation establishing a framework to strengthen the Union's biotechnology and biomanufacturing sectors, particularly in health, and amending several existing regulations.
The opinion was transmitted to the President of the Council of the European Union and is now circulated to delegations. It represents a formal scrutiny by a national parliament under the EU's early warning system for subsidiarity. The Italian Chamber of Deputies has not yet made its full reasoning public, but the submission triggers a review period during which other national parliaments may also issue reasoned opinions if they consider the proposal violates subsidiarity.
The European Biotech Act, proposed by the Commission in 2025, aims to boost the EU's biotechnology and biomanufacturing sectors with a focus on health applications. It would amend regulations on food safety, advanced therapies, clinical trials, veterinary medicinal products, and other areas. The proposal is currently under negotiation between the European Parliament and the Council.
If one-third of national parliaments issue reasoned opinions, the Commission must review the proposal. The Italian opinion is the first known subsidiarity challenge to the Biotech Act. The deadline for other parliaments to submit opinions is typically eight weeks from the proposal's transmission.
The opinion's impact on stakeholders is moderate. For EU regulatory bodies, it introduces a potential delay if a yellow card is triggered. For national authorities, it reinforces their role in scrutinizing EU competence. For the biotech industry, any delay could slow access to harmonized rules, while public health advocates may see it as a safeguard against overreach. The trade-off is between EU-level efficiency and national sovereignty over health policy.